Delving into the Latest Updates on Timdarpacept with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Recombinant human signal regulating protein alpha (SIRPalpha) fragment crystallizable (Fc)-fusion protein (ImmuneOnco), IMC-001, IMC001

+ [3]

Target

CD47

Mechanism

CD47 inhibitors(Cluster of differentiation 47 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [8]

Active Indication

Chronic Myelomonocytic LeukemiaClassical Hodgkin's LymphomaRefractory Classic Hodgkin Lymphoma+ [12]

Inactive Indication

B-Cell LymphomaExtranodal NK-T-Cell LymphomaMultiple Myeloma+ [5]

Originator Organization

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

Active Organization

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (US)

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Structure/Sequence

Sequence Code 942330967

Source: *****

This study is an IIT clinical study to evaluate the efficacy and safety of IMC-001 for injection on improved atherosclerotic plaque stability in patients receiving optimal medical therapy after a recent acute coronary syndrome (ACS). The study was a single-center, simple randomized, controlled study, in which the experimental group was given IMC-001 and the best drug treatment, and 8 subjects were included, and the control group was given only the best drug treatment, and 6 subjects were included.

Start Date19 Feb 2025

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

[+2]

NCT06647862

/ RecruitingPhase 3

A Randomized, Controlled, Double-Blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of IMM01 (Timdarpacept) in Combination With Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.

Start Date24 Oct 2024

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

CTR20241938

/ RecruitingPhase 3

注射用IMM01（替达派西普）联合替雷利珠单抗对比研究者选择的化疗方案治疗抗PD-(L)1单抗难治性经典型霍奇金淋巴瘤（cHL）受试者的随机、开放、对照、多中心III期临床研究

[Translation] A randomized, open-label, controlled, multicenter phase III clinical study of IMM01 (tiedapircept) for injection combined with tislelizumab versus chemotherapy selected by the investigator in the treatment of subjects with classical Hodgkin lymphoma (cHL) refractory to anti-PD-(L)1 monoclonal antibodies

基于2014 Lugano淋巴瘤疗效评价标准评估注射用IMM01联合替雷利珠单抗治疗抗PD-(L)1单抗难治性cHL患者的PFS。

[Translation]

The PFS of IMM01 for injection combined with tislelizumab in the treatment of cHL patients refractory to anti-PD-(L)1 monoclonal antibody was evaluated based on the 2014 Lugano lymphoma efficacy evaluation criteria.

Start Date17 Jun 2024

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup

100 Clinical Results associated with Timdarpacept

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100 Translational Medicine associated with Timdarpacept

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100 Patents (Medical) associated with Timdarpacept

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100 Deals associated with Timdarpacept

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Myelomonocytic Leukemia	Phase 3	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	24 Oct 2024
Classical Hodgkin's Lymphoma	Phase 3	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	01 Jun 2024
Refractory Classic Hodgkin Lymphoma	Phase 3	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	01 Jun 2024
Myelodysplastic Syndromes	Phase 3	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	-
Solid tumor	Phase 3	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	-
Acute Coronary Syndrome	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	19 Feb 2025
Plaque, Atherosclerotic	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	19 Feb 2025
Hepatocellular Carcinoma	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	17 May 2022
Nasopharyngeal Carcinoma	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	17 May 2022
Non-Small Cell Lung Cancer	Phase 2	CN	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.Startup	17 May 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05833984 (ESMO2024) Manual	Phase 2	Classical Hodgkin's Lymphoma	33	Timdarpacept tislelizumab	ppfgmerofj(fhojcqpxxq) = zudgguffsy gfivqtynrj (vkjcvksxhn ) View more	Positive	15 Sep 2024
NCT05140811 (ESMO2024) Manual	Phase 2	Chronic Myelomonocytic Leukemia First line	22	Timdarpaceptazacitidine	jgavrohjnn(vbmtenjrdi) = gezqokrqce xwwfhlccgl (vfmnqubthp ) View more	Positive	13 Sep 2024
NCT05140811 (phase 2 study of IMM01 combined with azacitidine (AZA), ASCO2024)	Phase 2	High Risk Myelodysplastic Syndrome First line DNMT3A \| ASXL1 \| U2AF1 ... View more	57	IMM01 + Azacitidine	xmahcbqgrf(jtnigugqcj) = only 1.8% koqgnzrubb (opefcbfzuw ) View more	Positive	24 May 2024
NCT05833984 (IMM01-04, ASCO2024)	Phase 2	Classical Hodgkin's Lymphoma PD-1	33	IMM01 (2.0mg/kg)	rqpgenjodz(kdtuemcueg) = mnrkcgmqry vyyptbvpqk (nhmordpymb ) View more	Positive	24 May 2024
NCT05833984 (IMM01-04, ASH2023)	Phase 2	Classical Hodgkin's Lymphoma	32	IMM01 plus tislelizumab	rytaydkgnn(nrdzhxenej) = iovpqdqylu dwsacukvts (zgoejsgcov ) View more	Positive	10 Dec 2023
NCT05140811 (ASH2023)	Phase 2	High Risk Myelodysplastic Syndrome First line	54	IMM01 + Azacitidine	qdbqbdxbes(zfocxroasc) = leukopenia (81.5%), thrombocytopenia (68.5%), neutropenia (66.7%), lymphopenia (57.4%), anemia (44.4%) and infection(16.7%) ocymwuybdr (hdgevhuzmt ) View more	-	09 Dec 2023
NCT05140811 (ASH2023)	Phase 2	Chronic Myelomonocytic Leukemia First line	24	IMM01 + AZA	nfzkrzsqir(kavcmcaibu) = 25.0% knzptmvyqr (asxszhezdi ) View more	-	09 Dec 2023
CTR20220791 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors \| Lymphoma	14	Tislelizumab+IMM01	rcncgnskpp(bcxsuurjbz) = kopiikxcuq lluemmedaz (goyfoqueyy ) View more	Positive	26 May 2023